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NEW YORK (360Dx) – Oxford Gene Technology announced today the US Food and Drug Administration has granted de novo classification for eight of the company's Cytocell Aquarius Haematology fluorescence in situ hybridization probes for acute myeloid leukemia and myelodysplastic syndromes.

The probes reduce the level of validation needed in laboratories and provide accurate, easy-to-interpret detection of chromosomal rearrangements reported in AML and MDS, according to UK-based OGT.

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Oct
09
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PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.